This ISO 13485 Internal Auditor Training is intended particularly for companies that produce or service medical devices or are part of an FDA regulated industry. It addresses the concerns specific to the medical device industry including risk management, software validation and supplier management.
ISM AUDITOR
ISO 13485 2016 INTERNAL AUDITOR
This ISO 13485 Internal Auditor Training addresses how management systems (MS) conforming to ISO 13485 apply to the medical device industry and how to develop a management system that conforms for ISO 13485 certification.
- Interpret and apply the requirements of ISO 13485:2016
- Apply ISO 14971
- Use the QMS and ISO 13485 to ensure compliance to applicable regulations
- Implement regulatory issues with minimal impact upon operations
- Identify and implement the controls necessary for ensuring the QMS consistently meets requirements
- Develop reliable and pliable systems, particularly effective for organizations where process objectives are constantly changing
- Determine and communicate the resources necessary for the system to work as planned
- Communicate the roles and responsibilities within the QMS to the organization
- Relate the capabilities of the organization to the expectations of customers, top management and shareholders
- Use the QMS to work proactively and not reactively, manage risk, validate software and manage suppliers
- Medical device professionals
- Professionals from FDA regulated industries
- Quality professionals
- ISO Managers/Management Reps
- Internal Auditors
- Process owners
- Systems professionals or people who want to understand how management systems work
- Improvement Specialists
- Buyers in FDA regulated industries
- Leaders/managers/professionals in the Medical Device industry
DAY 1
- Lecture: Intro to Management Systems
- Lecture: Internal Audit
- Lecture: Internal Audit Planning and Preparation
- Workshop: ISO 13485 – Review System Docs and Prep Audit Schedule
- Workshop: ISO 13485 – Reviewing Processes and Prep Checklists
DAY 2
- Lecture: ISO 13485
- Test: ISO 13485 Self Study
- Lecture: Performing the Internal Audit Investigation
- Workshop: ISO 13485 – Determining Nonconformities
- Lecture: Concluding the Audit
DAY 3
- Lecture: Corrective Action and Follow-up
- Workshop: Writing Nonconformity Statements
- Workshop: ISO 13485 – Interviewing Auditees
Students successfully completing QMII’s 3-day ISO 13485 Internal Auditor training and the examinations provided in conjunction with this course, receive a Certificate of Attainment for the following QMII training units:
- Interpret and apply the requirements of ISO 13485:2016
- Apply ISO 14971
- Use the QMS and ISO 13485 to ensure compliance to applicable regulations
- Implement regulatory issues with minimal impact upon operations
- Identify and implement the controls necessary for ensuring the QMS consistently meets requirements
- Develop reliable and pliable systems, particularly effective for organizations where process objectives are constantly changing
- Determine and communicate the resources necessary for the system to work as planned
- Communicate the roles and responsibilities within the QMS to the organization
- Relate the capabilities of the organization to the expectations of customers, top management and shareholders
- Use the QMS to work proactively and not reactively, manage risk, validate software and manage suppliers
- Medical device professionals
- Professionals from FDA regulated industries
- Quality professionals
- ISO Managers/Management Reps
- Internal Auditors
- Process owners
- Systems professionals or people who want to understand how management systems work
- Improvement Specialists
- Buyers in FDA regulated industries
- Leaders/managers/professionals in the Medical Device industry
DAY 1
- Lecture: Intro to Management Systems
- Lecture: Internal Audit
- Lecture: Internal Audit Planning and Preparation
- Workshop: ISO 13485 – Review System Docs and Prep Audit Schedule
- Workshop: ISO 13485 – Reviewing Processes and Prep Checklists
DAY 2
- Lecture: ISO 13485
- Test: ISO 13485 Self Study
- Lecture: Performing the Internal Audit Investigation
- Workshop: ISO 13485 – Determining Nonconformities
- Lecture: Concluding the Audit
DAY 3
- Lecture: Corrective Action and Follow-up
- Workshop: Writing Nonconformity Statements
- Workshop: ISO 13485 – Interviewing Auditees
Students successfully completing QMII’s 3-day ISO 13485 Internal Auditor training and the examinations provided in conjunction with this course, receive a Certificate of Attainment for the following QMII training units:
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